Analyses of Pimavanserin Studies Evaluating Treatment in Alzheimer’s Disease Psychosis and Parkinson’s Disease Psychosis Published in The Journal of Prevention of Alzheimer’s Disease Suggest Potential for Treating Dementia-Related Psychosis

SAN DIEGO--(BUSINESS WIRE)--Sep. 10, 2018--
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) announced today publication
of additional data from a Phase 2 single center, double-blind,
placebo-controlled study to examine the safety and efficacy of
pimavanserin for the treatment of psychosis in Alzheimer’s Disease
Psychosis in The Journal of Prevention of Alzheimer’s Disease (JPAD).
These results further demonstrate that pimavanserin may have the
potential to treat dementia-related psychosis, a condition which can be
present in neurodegenerative diseases such as Alzheimer’s disease,
dementia with Lewy Bodies, dementia associated with Parkinson’s disease,
vascular dementia and frontotemporal dementia-spectrum disorders.

The publication (https://link.springer.com/article/10.14283/jpad.2018.30)
focused on the pre-specified analysis in the subgroup of patients who
had more pronounced psychotic symptoms at baseline. In this subgroup of
patients with more severe delusions and hallucinations, at the primary
efficacy endpoint, pimavanserin demonstrated significant improvement
relative to placebo with a similar and acceptable tolerability profile.
These results were also presented recently at the Alzheimer’s
Association International Conference in Chicago in July 2018. The
primary results from the study were previously reported at the Clinical
Trials in Alzheimer’s Disease (CTAD) conference in Boston in October
2017 and published in the Lancet Neurology in March 2018.

“The robust efficacy of pimavanserin in patients with more severe
psychotic symptoms is relevant to the therapeutic benefits of
pimavanserin in a patient population with Alzheimer’s disease and
psychosis,” said lead investigator Clive Ballard, MBChB, MRCPsych,
Pro-Vice-Chancellor and Executive Dean, University of Exeter Medical
School. “These results extend and confirm the results from the primary
analysis as well as results from the subgroup analysis of patients with
mild dementia in the pivotal Parkinson’s disease psychosis study with
pimavanserin. These findings, coupled with the results from other
studies of pimavanserin, suggest a potential role for pimavanserin in
treating dementia-related psychosis in patients across a range of
neuropsychiatric conditions.”

A separate review published in JPAD (https://link.springer.com/article/10.14283/jpad.2018.29)
also supports the potential use of pimavanserin in other forms of
neurodegenerative diseases, including dementia-related psychosis. A
research group led by Jeffrey Cummings, MD, ScD, of the Cleveland Clinic
Lou Ruvo Center for Brain Health, Las Vegas, NV, looked at the clinical
evidence that has been gathered to date that supports the potential
efficacy of pimavanserin in dementia-related psychosis. “Clinical
evidence is now available that supports potential efficacy of
pimavanserin in dementia-related psychosis. This includes results from a
sub-analysis of mildly demented patients in the Phase 3 pivotal study in
patients with Parkinson’s disease psychosis, and the Phase 2 study in
patients with Alzheimer’s disease. Based on the overlap in clinical
presentation and pathology and the positive clinical trial results in
two neurodegenerative patient populations, we think it is important to
continue to evaluate pimavanserin’s effect in patients with
hallucinations and delusions across a number of neurodegenerative
disorders,” said Dr. Cummings.

ACADIA is currently conducting the Phase 3 HARMONY study in
dementia-related psychosis. This is a randomized withdrawal study
designed to evaluate the efficacy of pimavanserin in preventing relapse
of psychotic symptoms in patients with dementia-related psychosis.
Patients whose dementia-related hallucinations and delusions respond to
12 weeks of open-label treatment with pimavanserin are randomized, in a
double-blinded manner to continue pimavanserin therapy or to placebo.
The primary endpoint of this study is the average time to relapse
between pimavanserin and placebo. Studies suggest that 30% of patients
with dementia have psychosis, commonly consisting of hallucinations and
delusions. Serious consequences have been associated with severe or
persistent psychosis in patients with dementia. These consequences can
impact both patients and their families. Medications that are currently
used off-label to treat dementia related psychosis have been shown to
impair cognition in this already impaired population.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has developed and is
commercializing the first and only medicine approved for the treatment
of hallucinations and delusions associated with Parkinson’s disease
psychosis. In addition, ACADIA has ongoing clinical development efforts
in additional areas with significant unmet need including
dementia-related psychosis, schizophrenia inadequate response,
schizophrenia-negative symptoms, major depressive disorder and Rett
syndrome. This press release and further information about ACADIA can be
found at: www.acadia-pharm.com.

Forward-Looking Statements.

Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include, but are
not limited to, statements related to the potential benefits of
pimavanserin in patients with dementia-related psychosis. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties. Actual
events or results may differ materially from those projected in any of
such statements due to various factors, including the risks and
uncertainties inherent in drug discovery, development, approval and
commercialization, and the fact that past results of clinical trials may
not be indicative of future trial results. For a discussion of these and
other factors, please refer to ACADIA’s annual report on Form 10-K for
the year ended December 31, 2017 as well as ACADIA’s subsequent filings
with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.